One-year open-label safety evaluation of the fixed combination of ibuprofen and famotidine with a prospective analysis of dyspepsia

References

• Brooks, PM. The burden of musculoskeletal disease – a global perspective. Clin Rheumatol 2006;25:778-81
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention. Prevalence of doctor-diagnosed arthritis and arthritis-attributable activity limitation – United States, 2010–2012. Morb Mortal Wkly Rep 2013;62:869-73
   PubMed Web of Science ®Google Scholar
• Global burden of disease, 2004. World Health Organization, 2004. Available at: http://www.who.int/healthinfo/global_burden_disease/2004_report_update/en/ [Last accessed 7 May 2014]
   Google Scholar
• Ma VY, Chan L, Carruthers KJ. Incidence, prevalence, costs, and impact on disability of common conditions requiring rehabilitation in the United States: stroke, spinal cord injury, traumatic brain injury, multiple sclerosis, osteoarthritis, rheumatoid arthritis, limb loss, and back pain. Arch Phys Med Rehabil 2014;95:986-95
   PubMed Web of Science ®Google Scholar
• Bello AE, Kent JD, Grahn AY, et al. Risk of upper gastrointestinal ulcers in patients with osteoarthritis receiving single-tablet ibuprofen/famotidine versus ibuprofen alone: pooled efficacy and safety analyses of two randomized, double-blind, comparison trials. Postgrad Med 2014;126:82-91
   PubMed Web of Science ®Google Scholar
• Coxib and traditional NSAID Trialists’ (CNT) Collaboration, Bhala N, Emberson J, et al. Vascular and upper GI effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomized trials. Lancet 2013;382:769-79
   PubMed Web of Science ®Google Scholar
• Laine L, Kivitz AJ, Bello AE, et al.; on behalf of the REDUCE-1 and -2 Study Investigators. Double-blind randomized trials of single-tablet ibuprofen/high-dose famotidine vs ibuprofen alone for reduction of gastric and duodenal ulcers. Am J Gastroenterol 2012;107:379-86
   PubMed Web of Science ®Google Scholar
• Laine L. GI risk and risk factors of NSAIDs. J Cardiovasc Pharmacol 2006;47(Suppl 1):S60-6
   PubMed Web of Science ®Google Scholar
• Larkai EN, Smith JL, Lidsky MD, Graham DY. Gastroduodenal mucosa and dyspeptic symptoms in arthritic patients during chronic nonsteroidal anti-inflammatory drug use. Am J Gastroenterol 1987;82:1153-8
   PubMed Web of Science ®Google Scholar
• Taha AS, Hudson N, Hawkey CJ, et al. Famotidine for the prevention of gastric and duodenal ulcers caused by nonsteroidal antiinflammatory drugs. N Engl J Med 1996;334:1435-9
   PubMed Web of Science ®Google Scholar
• Goldstein JL, Hochberg MC, Fort JG, et al. Clinical trial: the incidence of NSAID-associated endoscopic gastric ulcers in patients treated with PN 400 (naproxen plus esomeprazole magnesium) vs. enteric-coated naproxen alone. Aliment Pharmacol Ther 2010;32:401-13
   PubMed Web of Science ®Google Scholar
• Bangalore S, Kamalakkannan G, Parkar S, Messerli FH. Fixed-dose combinations improve medication compliance: a meta-analysis. Am J Med 2007;120:713-19
   PubMed Web of Science ®Google Scholar
• Antman EM, Bennett JS, Daugherty A, et al. Use of nonsteroidal antiinflammatory drugs, an update for clinicians: a scientific statement from the American Heart Association. Circulation 2007;115:1634-42
   PubMed Web of Science ®Google Scholar
• Bello AE, Holt RJ. Cardiovascular risk with non-steroidal anti-inflammatory drugs: clinical implications. Drug Saf 2014;37:897-902
   Google Scholar
• COX-2 selective (includes Bextra, Celebrex, and Vioxx) and non-selective non-steroidal anti-inflammatory drugs (NSAIDs). Food and Drug Administration (FDA). Washington, DC, USA: FDA/Center for Drug Evaluation and Research, 7 April 2005. Available at: http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm103420.htm [Last accessed 16 April 2014]
   Google Scholar
• Duexis (prescribing information). Deerfield, IL, USA: Horizon Pharma Inc., 2012
   Google Scholar
• Schiff M, Peura D. HZT-501 (DUEXIS; ibuprofen 800 mg/famotidine 26.6 mg) GI protection in the treatment of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Exp Rev Gastroenterol Hepatol 2012;6:25-35
   PubMed Web of Science ®Google Scholar
• Kent JD, Holt RJ, Jong D, et al. Pharmacodynamic evaluation of intragastric pH and implications for famotidine dosing in the prophylaxis of non-steroidal anti-inflammatory drug induced gastropathy – a proof of concept analysis. J Drug Assess 2014;3:20-7
   PubMedGoogle Scholar
• Rainsford KD. Ibuprofen: pharmacology, efficacy and safety. Inflammopharmacol 2009;17:275-342
   PubMedGoogle Scholar
• Howden CW, Tytgat GNJ. The tolerability and safety profile of famotidine. Clin Therap 1996;18:36-54
   PubMed Web of Science ®Google Scholar
• Rabeneck L. Measuring dyspepsia-related health in randomized trials: the severity of dyspepsia assessment (SODA) and its use in treatment with NSAIDs and COX-2 specific inhibitors. Rheumatology 2003;42(Suppl 3):iii32-9
   PubMedGoogle Scholar
• Rabeneck L, Cook KF, Wristers K, et al. SODA (severity of dyspepsia assessment): a new effective outcome measure for dyspepsia-related health. J Clin Epidemiol 2001;54:755-65
   PubMed Web of Science ®Google Scholar
• Paulose-Ram R, Hirsch R, Dillon C, et al. Prescription and non-prescription analgesic use among the US adult population: results from the third National Health and Nutrition Examination Survey (NHANES III). Pharmacoepidemiol Drug Saf 2003;12:315-26
   PubMed Web of Science ®Google Scholar
• Trell S, Reichebach S, Wandel S, et al. Cardiovascular safety of non-steroidal anti-inflammatory drugs: network meta-analysis. BMJ 2011;342:c7086
   Google Scholar
• Lanza FL, Chan FKL, Quigley EMM. Guidelines for prevention of NSAID-related ulcer complications. Am J Gastroenterol 2009;104:728-38
   PubMed Web of Science ®Google Scholar
• Salvo F, Antoniazzi S, Duong M, et al. Cardiovascular events associated with the long-term use of NSAIDs: a review of randomized controlled trials and observational studies. Expert Opin Drug Saf 2014;13:573-85
   PubMed Web of Science ®Google Scholar
• Aljadhey H, Tu W, Hansen RA, et al. Comparative effects of non-steroidal anti-inflammatory drugs (NSAIDs) on blood pressure in patients with hypertension. BMC Cardiovascular Disorders 2012;12:93
   PubMed Web of Science ®Google Scholar
• Whelton A, Lefkowith JL, West CR, et al. Cardiorenal effects of celecoxib as compared with nonsteroidal anti-inflammatory drugs diclofenac and ibuprofen. Kidney Intern 2006;70:1495-502
   PubMed Web of Science ®Google Scholar
• Bello AE, Grahn AY, Ball J, Kent JD, Holt RJ. 1-year safety of ibuprofen/famotidine fixed combination versus ibuprofen alone: pooled analyses of two 24-week randomized, double-blind trials and a follow-on extension. Curr Med Res Opin 2015; in press
   Google Scholar